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Trial record 49 of 61 for:    "Lung Disease" | "Iloprost"

Examination of Ventavis (Iloprost) Inhalation Behavior Using the I-Neb AAD System in Patients With Pulmonary Arterial Hypertension When Switching the Iloprost Nebulizer Solution for Inhalation From 10 μg/mL (V10) to 20 μg/mL (V20) (VENTASWITCH)

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ClinicalTrials.gov Identifier: NCT02826252
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : March 15, 2017
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
The aim of this study is to examine inhalation behavior in patients enrolled in the German Ventavis patient support program Ventaplus when these patients are switched from Ventavis (Iloprost) 10 μg/mL to Ventavis (Iloprost) 20 μg/mL formulation.

Condition or disease Intervention/treatment
Hypertension, Pulmonary Drug: Iloprost,(Ventavis, BAYQ6256) Device: I-Neb AAD system

Detailed Description:
The VENTASWITCH study will be a local, prospective and retrospective, observational, case-crossover study. Data are collected and downloaded from the I-Neb AAD (Adaptive Aerosol Delivery) System. Two data collection periods are planned: period one; data collection from the last 3 months using Ventavis (Iloprost) 10 μg/mL (V10) before the index date of switching to Ventavis (Iloprost) 20 μg/mL (V20) (retrospective part) and period two; data collection for 3 months using V20 from index date (prospective part).

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Study Type : Observational
Actual Enrollment : 64 participants
Observational Model: Case-Crossover
Time Perspective: Other
Official Title: VENTASWITCH, Examination of Ventavis® (Iloprost) Inhalation Behavior Using the I-Neb® AAD® System in Patients With Pulmonary Arterial Hypertension When Switching the Iloprost Nebulizer Solution for Inhalation From 10 μg/mL (V10) to 20 μg/mL (V20)
Actual Study Start Date : September 15, 2016
Actual Primary Completion Date : November 15, 2016
Actual Study Completion Date : January 24, 2017


Group/Cohort Intervention/treatment
Ventavis
The study will be conducted in patients who are enrolled in the German Ventavis patient support program Ventaplus.
Drug: Iloprost,(Ventavis, BAYQ6256)
Ventavis (Iloprost) nebulizer solution for inhalation as 10 μg/mL (V10) and 20 μg/mL (V20).

Device: I-Neb AAD system
Nebulizer, allows digital recording of inhalation data such as doses, inhalations per day and duration of inhalation (per day) etc.




Primary Outcome Measures :
  1. Number of inhalations on Iloprost 10 ug/mL and 20 ug/mL [ Time Frame: Up to 6 months ]
  2. Number of delivered doses (none/partial/full) on Iloprost 10 ug/mL and 20 ug/mL [ Time Frame: Up to 6 months ]

Secondary Outcome Measures :
  1. Inhalation durations (min) per session on Iloprost 10 ug/mL and 20 ug/mL [ Time Frame: Up to 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will be conducted in patients who are enrolled in the German Ventavis patient support program Ventaplus which is executed for Bayer by the company Contra Care GmbH, Nürnberg. Patients who are enrolled in the program and repeatedly experienced extended inhalation times with Ventavis (Iloprost) 10 μg/mL which could possibly result in incomplete inhalations, are currently being switched to Ventavis (Iloprost) 20 μg/mL by their physician.
Criteria

Inclusion Criteria:

  • Patients aged ≥18 years at time of signing informed consent.
  • Patients, diagnosed with group 1 PAH.
  • Patients must be enrolled in the German Ventavis patient support program Ventaplus.
  • Patients who either already switched from V10 to V20 therapy or who agreed to do so according to their physician's decision.
  • Patients must have been on V10 therapy for at least 2 weeks.
  • Written informed consent must be obtained.

Exclusion Criteria:

- participation in other clinical or interventional study.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02826252


Locations
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Germany
Many locations, Germany
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02826252     History of Changes
Other Study ID Numbers: 18838
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: March 15, 2017
Last Verified: March 2017
Keywords provided by Bayer:
Pulmonary Arterial Hypertension (PAH)
Additional relevant MeSH terms:
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Lung Diseases
Iloprost
Respiratory Aspiration
Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Platelet Aggregation Inhibitors
Vasodilator Agents